FDA Archives - Page 192 of 220

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Ensysce Biosciences Announces Completion Of Clinical Portion Of Human Abuse Potential Trial PF614-103

August 23, 8:05 AM

Completion of Clinical Portion Represents Critical Milestone Towards Commercialization Nasal Opioid Abuse Being Explored for PF614 Data From Trial Expected in September 2022

ENSC

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Inhibikase Therapeutics Announces Dosing Of First Patient In Its Phase 2a ‘201’ Clinical Trial Of IkT-148009 To Treat Parkinson’s Disease

By Benzinga Newsdesk

August 23, 8:04 AM

nhibikase Therapeutics, Inc. (NASDAQ:IKT) (Inhibikase), a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson's disease and related disorders, today announced dosing of the

IKT

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Merck Gets FDA Fast Track Status For Chronic Kidney Disease Candidate

By Ragothaman Srinivasan

August 23, 7:29 AM

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Merck's (NYSE: MRK) lead asset MK-2060 for the reduction in risk of major thrombotic cardiovascular events in patients with end-stage renal disease (ESRD).

MRK

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Synlogic Granted FDA Fast Track Designation For SYNB1353 For Treatment Of Homocystinuria (HCU)

By Bill Haddad

August 23, 7:05 AM

CAMBRIDGE, Mass., Aug. 23, 2022 (GLOBE NEWSWIRE) -- Synlogic, Inc. (NASDAQ:SYBX), a clinical-stage biotechnology company developing medicines for metabolic and immunological diseases through its proprietary approach to

SYBX

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Foghorn Therapeutics Announces FDA Has Placed A Clinical Hold On Phase I Dose Escalation Study Of FHD-286

By Bill Haddad

August 23, 7:04 AM

Foghorn® Therapeutics Inc. (NASDAQ:FHTX), a clinical stage biotechnology company pioneering a new class of medicines that modulate gene expression through selectively targeting the chromatin regulatory system,

FHTX

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Recap Of Monday’s Biotech Catalysts – End Of the Day Summary

By Ragothaman Srinivasan

August 22, 7:10 PM

The U.S. Food and Drug Administration (FDA) has announced clearance to Insulet’s (NASDAQ:PODD) Omnipod 5 Automated Insulin Delivery…

BLTE

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Why Pharvaris Shares Are Plummeting Today?

By Vandana Singh

August 22, 3:45 PM

The FDA verbally placed a clinical hold on Pharvaris NV’s (NASDAQ:PHVS) PHA121 in the U.S. under two Pharvaris Investigational New Drug (IND)…

PHVS

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Minerva Seeks FDA Approval For Its Schizophrenia Candidate

By Vandana Singh

August 22, 11:38 AM

Minerva Neurosciences Inc (NASDAQ:NERV) submitted a marketing application to the FDA for roluperidone for negative symptoms in patients with schizophrenia. “We…

NERV